Medical device recalls
Device recalls are the largest single group in this archive, because the FDA logs corrections and removals as well as outright withdrawals. Many are handled entirely between the manufacturer and a hospital and need nothing from a patient. Each notice states who has to act.
13,634 stored notices, reported between Jun 20, 2012 and Sep 9, 2026. Newest first.
Reported Oct 15, 2025
Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
FDA (openFDA device enforcement)
Reported Oct 15, 2025
FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
Moderate riskThis product could cause temporary or reversible health problems — stop using it.FUJIFILM Healthcare Americas Corporation
FDA (openFDA device enforcement)
Reported Oct 15, 2025
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, SCS
FDA (openFDA device enforcement)
Reported Oct 15, 2025
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ImaCor Inc.
FDA (openFDA device enforcement)
Reported Oct 15, 2025
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Inpeco S.A.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 15, 2025
Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
FDA (openFDA device enforcement)
Reported Oct 15, 2025
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
High riskUsing this product could cause serious injury, illness or death — stop using it now.Noxbox Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 8, 2025
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap AG
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
FDA (openFDA device enforcement)
Reported Oct 8, 2025
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Oct 8, 2025
VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Change Healthcare Radiology Solutions software version 14.2.2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Change Healthcare Canada Company
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Getinge Disinfection Ab
FDA (openFDA device enforcement)
Reported Oct 8, 2025
1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MedicalCommunications GmbH
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medline Industries, LP
7 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
FDA (openFDA device enforcement)
Reported Oct 8, 2025
JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.North American Rescue LLC.
FDA (openFDA device enforcement)
Reported Oct 8, 2025
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Northeast Scientific Inc.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
14 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 8, 2025
IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.S.I.N. Implant System Ltda
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Schiller, Ag
FDA (openFDA device enforcement)
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RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.